Status:
WITHDRAWN
Peripheral Artery Occlusive Diseases (PAOD) Study - Clinical Assessment
Lead Sponsor:
RWTH Aachen University
Collaborating Sponsors:
Heinrich-Heine University, Duesseldorf
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To assess the clinical efficacy and to simultaneously explore the underlying molecular mechanisms of the beneficial effects of flavanol-rich cocoa on vascular function diabetic patients with periphera...
Detailed Description
50 Type 2 diabetics according to the criteria of the American Diabetes Association suffering from PAOD with a pain free walking distance less than 200 m will be enrolled. In a randomized controlled pa...
Eligibility Criteria
Inclusion
- Diabetes mellitus type 2 defined by the criteria of the American Diabetes Association
- Fasted plasma glucose greater than 126 mg/dL
- Plasma glucose levels greater than 200 mg/dL 2 hours after OGT
- Casual plasma glucose greater than 200 mg/dL combined with diabetic symptoms.
- Endothelial dysfunction defined by FMD \<4%
- No changes of medication for 2 months
- Significant PAOD (level IIb, III)
Exclusion
- Ejection fraction \<30%
- Malignoms
- Terminal renal failure with hemodialysis
- Relevant cardiac arrhythmias
- Acute inflammation defined as CRP \>0,5 mg/dl
- PAOD (level IV)
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00771797
Start Date
October 1 2008
End Date
December 1 2009
Last Update
September 23 2015
Active Locations (1)
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1
Heinrich-Heine-University, Düsseldorf
Düsseldorf, Germany, 40225